Home Applications 081318 Application 081318
Type ANDA
Sponsor ACP NIMBLE Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE JELLY;TOPICAL 2% No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A081318-001 LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 1993-04-29
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 2 · 41 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A081318-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 1993-04-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A081318-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 1993-04-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A081318-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 1993-04-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A081318-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 1993-04-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A081318-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 1993-04-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A081318-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 1993-04-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A081318-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 1993-04-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A081318-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 1993-04-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A081318-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 1993-04-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A081318-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 1993-04-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A081318-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 1993-04-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A081318-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 1993-04-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A081318-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 1993-04-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A081318-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 1993-04-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A081318-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 1993-04-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A081318-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 1993-04-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A081318-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 1993-04-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A081318-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 1993-04-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A081318-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 1993-04-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A081318-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 1993-04-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A081318-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 1993-04-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A081318-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 1993-04-29 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A081318-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 1993-04-29 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A081318-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 1993-04-29 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A081318-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 1993-04-29 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A081318-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 1993-04-29 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A081318-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 1993-04-29 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A081318-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 1993-04-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A081318-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 1993-04-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A081318-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 1993-04-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A081318-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 1993-04-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A081318-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 1993-04-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A081318-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 1993-04-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A081318-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 1993-04-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A081318-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 1993-04-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A081318-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 1993-04-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A081318-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 1993-04-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A081318-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 1993-04-29 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A081318-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 1993-04-29 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A081318-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 1993-04-29 cb3db0bc1861…
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 16 · 306 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Xylocaine MPF LIDOCAINE HYDROCHLORIDE Sportpharm LLC 50aa6133-0776-4714-9821-fe8581f635ca 2026-07-28 Warnings, Adverse reactions Name fallback generic name: LIDOCAINE HYDROCHLORIDE Aspercreme Lidocaine with Rosemary and Mint LIDOCAINE HYDROCHLORIDE Chattem, Inc. 9d40bfea-85d0-4943-83e9-0c16e79a011c 2026-07-28 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE AEROBURN LIDOCAINE HYDROCHLORIDE Aero Healthcare US LLC f8fa72db-5f7a-4158-a2b3-f8bc0e12df9f 2026-07-24 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE AEROBURN LIDOCAINE HYDROCHLORIDE Aero Healthcare US LLC a32cbc19-ec30-4634-b70d-664f2a2edd95 2026-07-24 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE Lidocaine hydrochloride LIDOCAINE HYDROCHLORIDE Medical Purchasing Solutions, LLC 573a7298-b02e-230c-e063-6294a90a269c 2026-07-22 Warnings, Adverse reactions Name fallback brand name: Lidocaine hydrochloride generic name: LIDOCAINE HYDROCHLORIDE Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. 462e9498-9eb9-456a-9022-659bcff93e3f 2026-07-17 Warnings, Adverse reactions Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE Painsil Pain Relief Roll-On LIDOCAINE HYDROCHLORIDE Painsil LLC dee39dff-5749-4ef2-a9ed-182f25e01f67 2026-07-14 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE Henry Schein, Inc. fa7dedcd-d78b-45f2-9dd7-f273043167d0 2026-07-14 Warnings, Adverse reactions Name fallback brand name: LIDOCAINE HYDROCHLORIDE generic name: LIDOCAINE HYDROCHLORIDE ZyloRelief LIDOCAINE HYDROCHLORIDE Highmark Pharma LLC 635f5b98-f74c-495f-a537-686fcba9ccad 2026-07-14 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE HF Acquisition Co LLC, DBA HealthFirst 2177b6fe-aa37-6f6b-e063-6294a90af09a 2026-07-10 Warnings, Adverse reactions Name fallback brand name: LIDOCAINE HYDROCHLORIDE generic name: LIDOCAINE HYDROCHLORIDE TopCare Health Pain Relief LIDOCAINE HYDROCHLORIDE Topco Associates LLC 485b0671-da09-19d7-e063-6294a90aca5d 2026-07-03 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE JJ Care BURN LIDOCAINE HYDROCHLORIDE Nantong Health & Beyond Hygienic Products Inc. d69ebc53-8552-449a-a973-f211328a3d3e 2026-07-03 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE Desert Harvest Releveum with Lidocaine LIDOCAINE HYDROCHLORIDE Desert Harvest, Inc 9ad514ab-a6bd-4564-8ba3-0149032ebf36 2026-07-01 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE Henry Schein, Inc. cfbca641-aeee-4dc8-a340-30c53d3b023b 2026-07-01 Warnings, Adverse reactions Name fallback brand name: LIDOCAINE HYDROCHLORIDE generic name: LIDOCAINE HYDROCHLORIDE Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE Hospira, Inc. 9c18eaf1-4a0b-4916-70b2-88a827494711 2026-06-24 Warnings, Adverse reactions Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE Lidozall Pro LIDOCAINE HYDROCHLORIDE V2 Pharma LLC ecc26ba7-4ff6-43e6-bfb9-91a9cbb509ff 2026-06-16 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE Civica, Inc. 3c3b3888-fad3-440b-b627-6f79a2f4668f 2026-06-10 Warnings, Adverse reactions Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE HealthWise Pain Relief Cream with Lidocaine LIDOCAINE HYDROCHLORIDE Veridian Healthcare ef176d33-10b9-ddb2-e053-2995a90a76e3 2026-06-10 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE Hospira, Inc. ad1ef0a8-88db-4648-c098-d009eaeb4e5b 2026-06-09 Warnings, Adverse reactions Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE Aspercreme with lidocaine No-Mess Applicator Two Pack LIDOCAINE HYDROCHLORIDE Chattem, Inc. 8092cde7-28d0-4755-b5c0-5765934e572f 2026-05-29 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE